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临床试验/CTRI/2015/03/005616
CTRI/2015/03/005616招募中不适用

COMPARISON OF PALANOSETRON AND ONDANSETRON ON ONSET OF POSTCRANIOTOMY NAUSEA AND VOMITING (POO-PCNV) TRIAL

PGIMER CHANDIGARH1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2014年9月6日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
76
试验地点
1
主要终点
Comparison of time duration for onset of PONV in neurosurgical patients following craniotomy with use of palanosetron when compared to ondansetron .

研究概览

简要总结

PONV( Post operative nausea and vomiting) is a frequent and distressing symptom after any type of neurosurgial procedure with a reported incidence of 44-70% in diffrent studies.In addition to cuasing patient discomfort  protracted PONV causes dehdration, acid-base disturbance, electrolyte imbalance which may effect the cerebral physiology and influence the outcome of the patient. Selective serotonin(5HT-3) antagonists are considered first choice for PONV owing to their safe profile and lack of serious side effects. Palanosetron have been found to be superioir to other serotonin anatgonists in phase 3 clinical trials in reducing early, immediate and delayed chemotherapy induced vomiting. No study has yet been done to evaluate the efficacy of palanosetron in the neurosurgical pouplation. Thus we planned  a prospetive randomized, double blind , controlled clinical trial to compare the efficacy of ondansetron and palanosetron in reducing PONV in patients undergoing neurosurgery. We will also assess corerelation of PONV with other factors sich as midline shift, mass effect, site and pathologic diagnosis of the tumour.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • •Patients scheduled for elective intracranial surgery •American Society of Anaesthesiologists (ASA) Grade I and II patients •Patients with Glasgow Coma Scale (GCS) of 15.

排除标准

  • •Patients with history of motion sickness •Pregnant patients •Breast feeding •Allergy to palanosetron •Morbid obesity •Cardiac dysrhythmias •Psychiatric illness •Chronic smokers •Those who have undergone ventriculo-peritoneal shunt.

结局指标

主要结局

Comparison of time duration for onset of PONV in neurosurgical patients following craniotomy with use of palanosetron when compared to ondansetron .

时间窗: 0 hr, 1 hr,6 hr,12 hr,24 hr,36 hr,48 hr,72 hrs .

次要结局

  • Comparison of palanosetron with ondansetron for - a) PONV scoring , b) incidence and severity of nausea, c) incidence of vomiting, d) length of postoperative hospital stay, e) side effects and f) patient satisfaction.(0 hr, 1 hr,6 hr, 12 hrs, 24 hrs, 36 hrs, 48 hrs,72 hrs)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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